Artemis Eye System
K-Number: K190719 · 2019-08-30
ApplicantPenumbra, Inc.
Decision Date2019-08-30
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Artemis Eye System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2019-08-30 under approval number K190719. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Artemis Eye System?
Artemis Eye System is a medical device that received FDA 510(k) clearance on 2019-08-30. It is manufactured by Penumbra, Inc.. The 510(k) number is K190719.
When was Artemis Eye System approved by the FDA?
Artemis Eye System received FDA 510(k) clearance on 2019-08-30, under approval number K190719.
What company makes Artemis Eye System?
Artemis Eye System is manufactured by Penumbra, Inc..
What is the FDA product code for Artemis Eye System?
The FDA product code for Artemis Eye System is GWG.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.